Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Completed · Not applicable

Conditions studied: Aortic Valve Disease, Aortic Valve Replacement

In brief

In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR). The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-TAVR procedure.

Key facts

Study ID

NCT06106451

Run by

Johns Hopkins University

People needed

40

Starts

2024-01-29

Expected to finish

2025-11-03

Last updated by the study team

2026-02-27

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing TAVR procedure
• ≥65 years old
• Ambulatory at baseline without assistance
• Approval of the interventional cardiologist that the patient is an appropriate candidate
• Can access telephone or teleconference

You may not qualify if…

• Impaired cognition that would limit participation in study activities
• Medical comorbidities that substantially limit exercise
• Major cardiac comorbidities, including ejection fraction<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator.
• Physical characteristics that substantially limit exercise
• High fall risk (Johns Hopkins Fall Risk Assessment Tool indicating high risk)
• Non-English Speaking
• Vigorous exercise at least 2 times/week for >30 minutes
• Any other physician judgement

Where it is running

• The Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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